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NCT Number: NCT03374774

A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to collect information about the participant's ability and willingness to pay for NovoMix 30 using a modern device, which is prescribed to the participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical practice. The study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or Penfill has been made independent from this study.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Guwahati, Assam, India

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- The decision to initiate treatment with commercially available BIAsp 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study - Patients selected by their physician for participation in the study, who are likely to be able and willing to pay for the BIAsp 30 treatment for at least 12 weeks from baseline visit as assessed by the treating physician - Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - Male or female greater than or equal to 18 years at time of informed consent - Diagnosed with T2DM and treated with BHI in vials for at least three consecutive months at time of informed consent Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Concurrent participation in any other clinical trial or study - Patients previously treated with insulin analogues - Known or suspected hypersensitivity to study product (or any of the excipients of the study product; a full list of excipients is provided in Summary of product characteristics (SmPC) of NovoMix® 30) or related products - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - Patients who are unable to read or write (illiterate)

Treatment and study plan

BIAsp 30

Drug

Participants will receive commercially available BIAsp 30 according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose.

Primary outcomes

  1. Proportion of patients who are using BIAsp 30 as their primary insulin

    Time frame: Week 12

    Proportion of patients

Secondary outcomes

  1. Demographic and socio-economic characteristics of patients still using BIAsp 30 and of patients no longer using BIAsp 30 as their primary insulin, measured by Ability to Pay Questionnaire

    Time frame: Week 12

    This questionnaire consists of a physician's part and a patient's part. The questionnaire reflects the socio-economic and lifestyle characteristics of patients.

  2. Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)

    Time frame: Week 0, week 12

    The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment.

  3. Change from baseline to Week 12 after first prescription of BIAsp 30 in patient evaluation of delivery system, measured by Treatment Related Impact Measure for Diabetes (TRIM-D) Device

    Time frame: Week 0, week 12

    The TRIM-D Device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change.

  4. Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)

    Time frame: Week 0

    This measure captures information on the convenience, user friendliness, and handling of pen, which is used to administer BIAsp 30. Seven items are scored on a 5 point scale from 'Not at all' to 'Extremely'. Proportion of each item to be presented.

  5. Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)

    Time frame: Week 0

    Through multiple scenarios, each patient will be prompted to select the choice that seems most favourable to the patient. Each scenario will consist of a bundled collection of attributes relevant for insulin therapy. The questionnaire consists of approximately nine questions/scenarios for each patient.

  6. Diabetes Pen Experience Measure (DPEM) Scores (frequency of each item)

    Time frame: Week 0

    This measure captures information on the convenience, user friendliness, and handling of pen, which is used to administer BIAsp 30. Seven items are scored on a 5 point scale from 'Not at all' to 'Extremely'. Frequency of each item to be presented.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre Prospective, Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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